The Effects of Transcranial Direct Current Stimulation on... | NCT01781065

Studies
The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury

NCT01781065

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Jul 15, 2013Estimated

Enrollment

16Actual

Phase

Phase 2

Conditions

Neuropathic Pain
Spinal Cord Injury

Interventions

transcranial direct current stimulation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jan 29, 2013

First Submission Date that Met QC Criteria

Jan 29, 2013

First Posted Date

Jan 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2013

Last Update Posted Date

Jul 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyung-Ik Shin, Associate Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain.

Detailed Description

anodal stimulation of the primary motor cortex (M1)
anode electrode: C3 (EEG 10/20 system)
cathode electrode: contralateral supraorbital area
constant current of 2mA intensity for 20 min
twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday, total 20 treatment session)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
transcranial direct current stimulation	Experimental	Anodal stimulation on motor cortex	Device: transcranial direct current stimulation
Sham transcranial direct current stimulation	Sham Comparator	Turn off after 10 s of stimulation	Device: transcranial direct current stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcranial direct current stimulation	Device		Sham transcranial direct current stimulation transcranial direct current stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numeric rating scale for average pain over the preceding 24h		before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation

Secondary Outcomes

Measure	Description	Time Frame
Patient global impression of change for pain		before the first tDCS session, and 1, 2, 4, 6, and 8 wk after the start of the stimulation

Other Outcomes

Measure	Description	Time Frame
Pain interference in general daily life, mood and sleep		before the first tDCS session, and 1, 2, 4, 6, 8 wk after start of the stimulation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elapsed time since spinal cord injury more than 6 months
stable chronic pain for at least 3 preceding months
pain that was not attributable to cause other that neuropathic pain
pain that was resistant to various types of medications or physical or complementary medicine treatment

Exclusion Criteria:

any kind of metal implant in the head
heart disease including having a cardiac maker
family or personal history of epilepsy, or neuropsychiatric illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyung Ik Shin	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-802	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16564618	Background	Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.

ID	Term
D009437	Neuralgia
D013119	Spinal Cord Injuries

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies